RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleuralmesothelioma without progressive disease after first-line chemotherapy.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: pemetrexed disodium

Given IV

Active Comparator: Arm II

Patients undergo observation until disease progression.

Other: clinical observation

Patients undergo observation

Detailed Description:

OBJECTIVES:

Primary

To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin.

Secondary

To determine the overall survival of patients treated with this regimen versus observation.

To evaluate the frequency of responses in patients treated with this regimen.

To assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium), histologic subtype (epithelioid vs other) and number of courses received (< 6 vs 6).

Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Arm II: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years.

Intermittent use of dexamethasone as an antiemetic or premedication for pemetrexed disodium

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01085630